MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2013-11-21 for MAINFRAME 8252001 NIM-RESPONSE 2.0 manufactured by Medtronic Xomed, Inc..
[17931527]
The facility reported they were unable to stimulate using nim 2. 0 and standard et tube; 'emg monitoring disabled' was displayed. There were no values for any channel or the ground electrode when the 'electrode check' was run. Patient interface box was disconnected and reconnected to the nim, then system was power cycled. They were then able to see values in the electrode check and 'emg monitoring disabled' message was no longer displayed. When they used stim probe, there was no response on the system. They elected to continue thyroid case without the nim. There was no report of patient impact.
Patient Sequence No: 1, Text Type: D, B5
[18094438]
This device is used for therapeutic purposes. (b)(4). Customer is not returning the device for evaluation. Method: no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[102472134]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00577 |
| MDR Report Key | 3482073 |
| Report Source | 06,USER FACILITY |
| Date Received | 2013-11-21 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-29 |
| Date Mfgr Received | 2013-10-29 |
| Date Added to Maude | 2014-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAINFRAME 8252001 NIM-RESPONSE 2.0 |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2013-11-21 |
| Model Number | 8252001 |
| Catalog Number | 8252001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-21 |